Edge AI-deployed DIGItal Twins for PREDICTing Disease Progression and Need for Early Intervention in Infectious and Cardiovascular Diseases Beyond COVID-19 - Evaluation of Physiological Sensors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Short-term kinetics of high sensitive troponin T
研究概览
简要总结
The study aims to investigate short-term physiological and biochemical inflammatory and cardiocirculatory biomarker kinetics in heart failure patients, using the DIGIPREDICT Physiopatch device - an investigational device that allows non-invasive realtime single-lead ECG registration and bioimpedance measurement as well as spotcheck photoplethysmography -, and standard laboratory methods, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of heart failure, defined as: symptoms and signs of heart failure, elevated baseline NT-proBNP levels (>125pg/ml in sinus rhythm, >365 pg/ml in atrial fibrillation) without severe kidney disease (defined as eGFR(MDRD)<30 ml/min/1.73m²), and structural and/or functional abnormalities (according to 2021 ESC Heart Failure Guidelines)
- •At least 2 days of further treatment on a DHZC intensive care unit (H3i, IPS1, IPS2) or intermediate care unit (H3 - heart failure unit) expected at enrolment.
- •Age of subject is ≥ 18years.
- •Subject is female, male, divers.
- •Signed written informed consent.
- •For female subject or divers subject:
- •Negative highly sensitive urine or serum pregnancy test before inclusion, and
- •Practicing a highly effective birth control method (failure rate of less than 1%):
- •combined (estrogen and progestogen containing) hormonal
- •contraception associated with inhibition of ovulation (oral/intravaginal/ transdermal), or
- •progestogen-only hormonal contraception associated with inhibition of ovulation (oral/injectable/implantable), or
- •intrauterine device (IUD), or
- •intrauterine hormone-releasing system ( IUS), or
- •bilateral tubal occlusion, or
- •vasectomised partner, or
- •heterosexual abstinence.
排除标准
- •Subject is breastfeeding.
- •Subject suffers from an addiction or from a disease that prevents the subject from recognizing nature, scope, and consequences of the study.
- •Subject is treated with immunosuppressive drugs at enrolment.
- •Subject requires mechanical circulatory support at enrolment (IABP, veno-arterial ECMO, Impella, VAD, TAH).
- •Subject requires extracorporeal lung support at enrolment (veno-venous ECMO, interventional lung assist).
- •Subject requires invasive ventilation at enrolment.
- •Subject requires renal replacement therapy.
- •Subjects with an active stimulation device (implanted or not) (e.g. pacemaker, nerve stimulator).
- •Subject has a known colonisation or infection with multi-drug-resistant pathogens.
- •Subject suffers from a skin disease at all possible placement sites for the DIGIPREDICT Physiopatch.
- •Subject has damaged skin at all fingertips.
- •Subject has highly sensitive skin to (medical) adhesives.
- •Subject shows an inability to comply with all of the study procedures and follow-up visits.
- •Subjects who are unwilling to consent to saving and propagation of pseudonymised medical data for study reasons.
- •Subject is legally detained in an official institution.
- •Subject is dependent on the sponsor, the investigator or the study sites.
- •Subject participates in another clinical investigation according to MPDG/MDR, or in a study according to AMG/CTR that investigates immunosuppressive drugs at the time of this study.
结局指标
主要结局
Short-term kinetics of high sensitive troponin T
时间窗: 4 days
Outcome is the detection of kinetics of high sensitive troponin T \[ng/L\] between at least two timestamps. Short-term is defined as \<= 26hours; biomarker kinetics are defined as \>20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.
Short-term kinetics of lactate
时间窗: 4 days
Outcome is the detection of kinetics of lactate \[mg/dL\] between at least two timestamps. Short-term is defined as \<= 26hours; biomarker kinetics are defined as \>20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.
Short-term kinetics of C-reactive protein
时间窗: 4 days
Outcome is the detection of kinetics of C-reactive protein values \[mg/L\] between at least two timestamps. Short-term is defined as \<= 26hours; biomarker kinetics are defined as \>20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.
Short-term kinetics of interleukin-6
时间窗: 4 days
Outcome is the detection of kinetics of interleukin-6 values \[ng/L\] between at least two timestamps. Short-term is defined as \<= 26hours; biomarker kinetics are defined as \>20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.
Short-term kinetics of ferritin
时间窗: 4 days
Outcome is the detection of kinetics of ferritin values \[µg/L\] between at least two timestamps. Short-term is defined as \<= 26hours; biomarker kinetics are defined as \>20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.
Short-term kinetics of blood pH
时间窗: 4 days
Outcome is the detection of kinetics of blood pH between at least two timestamps. Short-term is defined as \<= 26hours; biomarker kinetics are defined as \>20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.
Short-term kinetics of bioimpedance
时间窗: 4 days
Outcome is the detection of kinetics of bioimpedance \[Ohm\] between at least two timestamps. The mean value within 1 h before the timestamp of the concomitant biochemical biomarkers will be used for analysis. Short-term is defined as \<= 26hours; biomarker kinetics are defined as \>20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.
Short-term kinetics of procalcitonin
时间窗: 4 days
Outcome is the detection of kinetics of procalcitonin values \[ng/mL\] between at least two timestamps. Short-term is defined as \<= 26hours; biomarker kinetics are defined as \>20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.
Short-term kinetics of body surface temperature
时间窗: 4 days
Outcome is the detection of kinetics of body surface temperature \[°C\] between at least two timestamps. The mean value within 1 h before the timestamp of the concomitant biochemical biomarkers will be used for analysis. Short-term is defined as \<= 26hours; biomarker kinetics are defined as \>20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.
Short-term kinetics of NT-pro brain natriuretic peptide
时间窗: 4 days
Outcome is the detection of kinetics of NT-pro brain natriuretic peptide \[ng/L\] between at least two timestamps. Short-term is defined as \<= 26hours; biomarker kinetics are defined as \>20% increase or decrease of a biomarker level at one point in time compared to the level at another point in time. The timestamp documented in the electronic health record will be used for analysis.
次要结局
- Correlation between NT-pro brain natriuretic peptide and body surface temperature(4 days)
- Correlation between lactate and body surface temperature(4 days)
- Correlation between blood pH and body surface temperature(4 days)
- Correlation between C-reactive protein and bioimpedance(4 days)
- Correlation between interleukin-6 and bioimpedance(4 days)
- Correlation between ferritin and body surface temperature(4 days)
- Correlation between lactate and bioimpedance(4 days)
- Correlation between blood pH and bioimpedance(4 days)
- Correlation between procalcitonin and body surface temperature(4 days)
- Correlation between interleukin-6 and body surface temperature(4 days)
- Correlation between ferritin and bioimpedance(4 days)
- Correlation between C-reactive protein and body surface temperature(4 days)
- Correlation between procalcitonin and bioimpedance(4 days)
- Correlation between NT-pro brain natriuretic peptide and bioimpedance(4 days)
- Correlation between high sensitive troponin T and body surface temperature(4 days)
- Correlation between high sensitive troponin T and bioimpedance(4 days)
研究者
Laurenz Kopp Fernandes
Senior physician, Transplant Outpatient Unit
Charite University, Berlin, Germany